DECISION www.epa.govt.nz 11 December 2019 Overview Substances Paraquat and paraquat-containing substances Application code APP203301 Application type To reassess any hazardous substance under section 63 of the Hazardous Substances and New Organisms Act (“the Act”) Applicant The Chief Executive (“CE”) of the Environmental Protection Authority (“the EPA”) Purpose of the application The EPA has applied for the reassessment of paraquat and paraquat-containing substances Submissions received Adama New Zealand Limited Agpro NZ Limited Dairy NZ Department of Conservation – Auckland Conservancy Farmlands Co-operative Farmlands Grain & Seed Federated Farmers of New Zealand Horticulture New Zealand Market Access Solutionz Limited New Zealand Beekeeping Incorporated Pearler Bay Farm Potatoes New Zealand Syngenta Crop Protection Limited Te Wahapu o Hokianga Nui a Kupe P Foster A Talbot D Morton L Clapham Considered by A Decision-Making Committee of the Environmental Protection Authority
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DECISION
www.epa.govt.nz
11 December 2019
Overview
Substances Paraquat and paraquat-containing substances
Application code APP203301
Application type To reassess any hazardous substance under section 63 of the Hazardous
Substances and New Organisms Act (“the Act”)
Applicant The Chief Executive (“CE”) of the Environmental Protection Authority (“the
EPA”)
Purpose of the application The EPA has applied for the reassessment of paraquat and paraquat-containing
substances
Submissions received Adama New Zealand Limited
Agpro NZ Limited
Dairy NZ
Department of Conservation – Auckland Conservancy
Farmlands Co-operative
Farmlands Grain & Seed
Federated Farmers of New Zealand
Horticulture New Zealand
Market Access Solutionz Limited
New Zealand Beekeeping Incorporated
Pearler Bay Farm
Potatoes New Zealand
Syngenta Crop Protection Limited
Te Wahapu o Hokianga Nui a Kupe
P Foster
A Talbot
D Morton
L Clapham
Considered by A Decision-Making Committee of the Environmental Protection Authority
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Decision Paraquat (HSR003041), Soluble concentrate containing 115 g/litre diquat as the
dibromide salt and 135 g/litre paraquat as the dichloride salt (HSR000447) and
Soluble concentrate containing 200 - 250 g/litre paraquat as the dichloride salt
(HSR000828) are approved with additional controls.
(HSR007854)). The committee considered that as these substances were not in use they did not
present any benefit. Therefore, in accordance with section 29(1)(a) of the Act, the Committee
considered there were no positive effects of the substances HSR007847 and HSR007854 to outweigh
the adverse effects and decided to decline their approvals.
Consequently, the Committee determined that the approvals HSR003041, HSR000447 and
HSR000828 are re-approved with additional controls and that the approvals HSR007847,
HSR007854, HSR100443 and HSR100572 are declined. The effect of the decision to decline the
approvals HSR007847, HSR007854, HSR100443 and HSR100572 comes into effect 12 months after
the date of this decision.
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Table of Contents
Overview .................................................................................................................................................. i
Executive summary ................................................................................................................................ iii
Risks to the aquatic environment ......................................................................................................... 25
Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators ......... 25
Risks to non-target plants ..................................................................................................................... 26
Risks to pollinators ................................................................................................................................ 26
Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators ......... 26
Risks to birds ......................................................................................................................................... 26
Assessment of risks to society, the community, and the market economy ................................. 27
Assessment of benefits ..................................................................................................................... 27
Cultural assessment .......................................................................................................................... 28
New Zealand’s international obligations .......................................................................................... 28
Amendments to proposed controls by the Committee .................................................................... 28
Direction to dispose of substances with declined approvals ............................................................ 28
Guidance on packaging requirements .............................................................................................. 29
6 Conclusion and decision ................................................................................................................ 29
Appendix A: Controls applying to retained approvals .......................................................................... 31
Decision on the reassessment of paraquat and paraquat-containing substances (APP203301)
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prohibition of hand-held use, requirements to use closed cab application methods, and
additional record-keeping requirements.
2.8 Some submitters also indicated a number of issues with the methodology used by the EPA to
refine the risk assessment to produce the updated risk assessment provided with the EPA
update report.
2.9 The Committee took account of these submissions in making its decision and noted that the
EPA update report responded to these issues.
3 The EPA update report
3.1 The EPA update report provided responses to issues raised in submissions and contained an
update on the proposals detailed in the reassessment application document. It provided
information to assist the Committee to make its decision.
3.2 The EPA update report included the initial risk assessment as set out in the application form,
together with an updated risk assessment for paraquat, based on information provided by
submitters.
3.3 Confidential information was provided by multiple submitters, including Syngenta Crop
Protection Limited – the intellectual property owners for paraquat, which was taken into account
during the assessment of paraquat-containing substances. The confidential information
included study information on the human health and environmental adverse effects associated
with paraquat as well as economic information pertinent to the economic impact of paraquat.
3.4 The previous risk assessment2 on the use of a paraquat-containing substance found that the
risks to operators, re-entry workers, and bystanders were all non-negligible; and WorkSafe
agreed. The previous risk assessment on the aerial use of paraquat-containing substances also
found that the risks to soil organisms, non-target plants, sediment-dwelling organisms, and
birds were non-negligible. There were mixed impacts on beneficial arthropods.
3.5 The EPA proposed a suite of prescribed controls based on the hazard classifications of
paraquat and the paraquat containing substances which the EPA proposed for re-approval. The
EPA also considered variations to these controls, and the addition of extra controls, in
accordance with section 77 and section 77A of the Act.
3.6 The EPA update report concluded that the proposed use of some the paraquat containing
substances results in negligible/low risks to human health and the environment, when
appropriate controls are in place, and that the potential benefits were significant and non-
negligible. The EPA suggested that the overall benefit provided by the use of these paraquat
containing substances would outweigh the adverse effects, with the implementation of the
identified changes to controls.
3.7 The EPA update report noted that two of the approved substances triggered additional
Carcinogenicity, Mutagenicity or Reproductive Toxicity (CMR) hazard classifications, which
were triggered by co-formulants, such that these substances are associated with additional
risks. The EPA proposed in the application for reassessment that the inclusion of CMR
triggering components did not provide any additional benefit which might outweigh the
additional risks associated with these substances when compared to other paraquat-containing
2 For Para-Ken 250 (application APP202697)
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substances with similar use patterns. As no information was provided in the submissions which
the EPA considered to illustrate increased benefits provided by these substances, the EPA
maintained its proposal to not re-approve these two approvals.
3.8 The application and the EPA update report also noted that there were two approvals for which
there were no registered products under the ACVM Act and therefore these approvals were not
used. As no information was provided indicating the use or intention for use of these
substances, the assessment in the EPA update report was that no benefits were associated
with these approvals, while still having non-negligible risks, and therefore the proposal to not
re-approve these two approvals was maintained.
4 Hearing
4.1 On 11 and 12 September 2019, a hearing was held at Chartered Accountants – Wellington in
Wellington. Presentations were given by the EPA as the applicant, the Sapere Research Group
(Sapere), as an economic consultant on behalf of the EPA, and seven submitters.
4.2 One speaker, Stephen Salter, presented as part of Market Access Solutionz Limited (also
presenting on behalf of Potatoes New Zealand (Potatoes NZ) separately) which represented
the grower groups: Summerfruit New Zealand, Vegetables New Zealand, Process Vegetables
New Zealand, The New Zealand Buttercup Squash Council, and Onions New Zealand.
EPA presentation
4.3 The paraquat reassessment application was presented by representatives from the EPA.
4.4 They provided an overview of the history of paraquat as a herbicide, its regulatory history both
in New Zealand and in other jurisdictions, and the background to this application. The EPA
indicated that they had refined their initial risk assessments and resulting proposals based on
information provided in the submissions and call for information.
4.5 The EPA presented information on the risk assessment, outlining the changes in consideration
between this risk assessment and the risk assessment for application APP202697. The EPA
highlighted that there was a significant increase in data available from the call for information
compared to the more limited data set available for APP202697.
4.6 The EPA acknowledged that the initial approach was based on the methodology and endpoints
used for APP202697 which were subsequently refined following the provision of information
from Syngenta regarding the risk assessment to birds and aquatic plants. The changes to the
risk assessment were primarily concerned with the rapid adsorption of paraquat to sediment,
reducing the bioavailability of paraquat in the environment. This led to a decrease to the risks
associated with aquatic plant ecotoxicity and a reduction in the proposed buffer zone controls.
4.7 Regarding the revision of the risk assessment, the EPA noted that they agreed with Syngenta’s
proposed methodology but disagreed with the robustness of the studies used to produce the
acute and chronic toxicity endpoints. Instead the EPA selected a different endpoint following
review of the available literature and the scenarios used in the risk assessment modelling.
4.8 The EPA outlined the methodology and modelling for the human health risk assessment, and
selection of appropriate Acceptable Operator Exposure Levels (AOEL), no-observed-adverse-
effect-level (NOAEL) and Risk Quotient (RQ) values. The EPA outlined that there had been a
reduction in several classifications, but this did not affect the risk assessment which was based
on AOEL and NOAEL factors.
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4.9 The EPA presented the outcome of risk assessment modelling at different application rates and
with different use patterns for the paraquat containing substances. In particular they noted that
the risks associated with inhalation toxicity were not as high as would be expected due to lower
exposure rates illustrated in biological modelling. The EPA concluded that the revised
modelling indicated that a maximum application rate of 600 grams of active ingredient per ha (g
ai/ha) would be acceptable for boom and knapsack spraying, with controls in place.
4.10 The EPA noted the key points of the ecotoxicity profile of paraquat, highlighting the toxicity of
paraquat to terrestrial and aquatic plants including high toxicity to algae, high toxicity to birds,
and ecotoxicity to bees via oral and dermal exposure. The EPA also noted that the substance is
not ecotoxic to soil dwelling organisms. The EPA noted that paraquat is highly persistent and is
notably immobile in the soil environment, effectively being deactivated in contact with soil with a
soil adsorption coefficient (KOC) value of 15,473 millilitres per gram of content.
4.11 The EPA noted the risk assessment position taken for APP202697 resulted in the acute and
chronic risks to birds being considered to remain outstanding (contributing to the decision to
decline that substance). The revised risk assessment for birds across the scenarios relevant to
use in New Zealand, based on Syngenta’s methodology, resulted in acute risks to birds which
were below the Level of Concern (LOC) for all scenarios, however the chronic risks remained
above the LOC for pre-emergence and lucerne use scenarios.
4.12 The EPA presented the cultural risk assessment, noting that it was informed by the human
health and environmental risk assessments. The cultural risk assessment highlighted the
persistence of paraquat in soil and waterways and the risk to birds as concerning to Māori. The
EPA also noted that the cultural risk assessment supported the proposal to decline approvals
which were classified as CMR toxicants, as well as the proposed WorkSafe restrictions on
handheld use and closed cab application methods.
4.13 The EPA noted the submissions received, recording a range of positions on the approval status
from people that wanted to ban paraquat outright, to people that supported the use of paraquat,
as well as the restrictions that had been proposed in the application form. The largest group
was represented by the submitters who supported the re-approval of paraquat but opposed the
additional controls that were proposed in the application form.
4.14 The EPA spoke to the benefit assessment, revised risk assessment and revised proposals for
changes to the approvals and controls for paraquat herbicides. The EPA noted the economic
benefits case as prepared by Sapere, relating this to the different possible application rates
proposed, with a 600 g ai/ha application rate having the least impact on GDP while significantly
mitigating risks. The EPA spoke to the different benefits associated with different use patterns
and related this to their proposed use pattern restrictions.
4.15 It was highlighted that the significant benefits provided by biosecurity use are to be
incorporated into the proposed use patterns, and that forestry did not appear to be a significant
sector of use. The EPA set out that they were maintaining their proposal for mandatory
responsible handling requirements, highlighting that similar resources were available in other
jurisdictions. However, the requirement proposed in the application for completion of an
accompanying declaration of understanding would not be implemented. The EPA also stated
that any restrictions around handheld use would fall under the jurisdiction of WorkSafe rather
than the EPA.
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Committee questions
4.16 The Committee asked the EPA to clarify the relationship of the acute toxicity of paraquat with
its associated human health risks. The EPA responded, clarifying that the acute toxicity
inhalation value is derived through a study methodology and that value is not likely to be
achieved in the practical use of the substance, and that the oral and dermal exposure routes
may be more relevant, but also adding that systemic damage to the lung was the route for
toxicity. The EPA clarified that the risks account for various factors in addition to the hazard
classification, and that different substances cannot be compared for risk based on hazard
assignment.
4.17 The Committee asked if the EPA could provide some comment on the history of medical
incidents associated with the use of paraquat in New Zealand and if there was any comparison
with other herbicides. The EPA noted that the majority of incidents related to accidental
exposure or an end user not using the appropriate personal protective equipment (PPE). They
identified one or two overseas cases where the substance leaked from equipment and the user
was not wearing adequate PPE such that there was sufficient dermal exposure and absorption
to cause an effect.
4.18 Furthermore, it was noted that New Zealand coroner data suggests that paraquat poisonings
have decreased since the Act came into force. The EPA staff highlighted that a number of the
proposed controls, such as the requirement to include emetic and stenching agents, are
designed to mitigate accidental poisoning situations. The EPA also noted that a significant
proportion of poisonings in the recorded data were intentional. The EPA acknowledged that
they do not have any comparative data for other herbicides of similar use.
4.19 The Committee then asked for clarification regarding the exposure risks to birds. The EPA
responded clarifying that this was the chronic risk to birds, with the acute risk being below the
LOC for all proposed application rates. The EPA outlined that the chronic exposure risk occurs
via consumption of contaminated matter, being seeds, insects and other food sources and that
this was assumed in the modelling where the effect being modelled is essentially chronic
exposure from a single spraying event.
4.20 The EPA also noted that the exposure of birds to the substance would be determined by its
bioavailability, where binding with soil significantly limits the bioavailability. The EPA noted that
to release paraquat from the soil requires significantly extreme conditions to destroy the soil
such that the long term half-life is unlikely to result in longer term risks to birds foraging on the
ground in an area that has been sprayed. The Committee requested information on whether
such conditions would be present in a bird’s stomach and what the lifetime of ingested paraquat
material would be. The EPA noted these questions and deferred answering these to Syngenta
as the intellectual property owner who may hold this information, or to the EPA’s right of reply
later in the hearing.
4.21 The Committee asked what evidence there was for paraquat accumulating in bird food sources
to justify an assumption of 70% of food being the major exposure pathway in the modelling, and
whether there was evidence of biomagnification or bioaccumulation. The EPA acknowledged
that there was an absence of information on birdlife habits in New Zealand and therefore the
assumption that at the relevant points that birds would be foraging in the area and consuming
material. The EPA noted these questions and deferred answering these to Syngenta as the
intellectual property owner who may hold this information, or to the EPA’s right of reply later in
the hearing.
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4.22 The Committee questioned why a maximum application rate of 600 g ai/ha was proposed
where this would exceed the LOC for chronic risks to birds. The EPA explained that the
estimated level of risk in the revised risk assessment for an application rate of 600g ai/ha was
below the level of risk estimate accepted for an application rate of 400 g ai/ha in the original
application risk assessment. Therefore, it was considered that if level of risk was acceptable in
the application, a lower level of risk should be acceptable in the refined assessment.
Furthermore, the EPA noted that the additional application rate provided a significant economic
benefit increase which was considered to offset the risks associated with the increased
application rate. The Committee noted that there were further concerns to be addressed in the
area of the bird risk assessment.
4.23 The Committee requested clarification on the use sectors for the substance, notably whether
forestry is proposed to be included, and on the definition of horticulture vs ornamental
horticulture. The EPA clarified that there was little to no forestry use noted in the call for
information or submissions and therefore it was considered that paraquat provided little to no
benefit in this area.
4.24 The EPA also clarified that it was intended for the agriculture definition to incorporate forestry,
nurseries and production style horticulture, including ornamental horticulture which they
proposed had similar use patterns as agriculture, however noting the intent to exclude
horticulture in public amenity spaces and home use. The Committee noted that horticulture is
broadly quite a different use pattern and that the use patterns would need to be well defined.
4.25 The Committee observed the lack of iwi submissions considering there was a significant
cultural assessment, and that there would have been an expected input in both the cultural and
economic spaces from Iwi.
4.26 The Committee queried if the KOC values applied to all soil types. They continued, asking
whether paraquat may be released under anoxic conditions during runoff events or other
situations where the material may enter a lake or aquatic system. They asked if waterbodies
with stratification such that there are low Dissolved Oxygen and anoxic soil conditions which
result in a low pH and redox potentiality changes may cause a possible release of material. The
EPA noted that their information indicated that paraquat binds extremely well to aquatic soils,
and that further information would be provided in the right of reply.
4.27 The Committee queried the proposed use of the substances under a permission for biosecurity
and whether this may involve higher application rates in order to be effective for this use
pattern, with these uses assessed on a case by case basis. The Committee highlighted that
there may be issues with the practicalities of WorkSafe assessments for these uses. The EPA
confirmed that there may be some issues regarding the setting of WorkSafe requirements,
however, they otherwise considered that the Permission control would allow them to assess the
specific risks and benefits of any operation on a case by case basis.
Submitter questions
4.28 Stephen Salter (on behalf of Market Access Solutionz Limited) noted that the EPA had
referenced the Australian Pesticides and Veterinary Medicines Authority (APVMA) Australian
risk assessment for paraquat and noted that the conclusion of this decision was that no
available data impacted the approval status of paraquat in Australia.
4.29 Mr Salter noted that the permission control as applied to sodium nitrate baits does not require a
permission for use on DoC controlled land, and wondered if a similar arrangement was
considered with MPI, either in general or where the proposed use meets the controls assigned
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to paraquat containing substances for agricultural uses. The EPA acknowledged that they had
not considered delegation but noted that they would be reluctant to delegate the sign off
responsibility if the Committee were to allow permissions for biosecurity use as they would want
to ensure that the environmental and human health expertise was present to assess deviations
from the risk assessment and mitigations set for agriculture.
4.30 Mr Salter requested that the Committee and the EPA clarify what a non-target plant is in the
decision controls to avoid inadvertent non-compliance, as well as clarifying whether forestry
nursery use is included in the definition of agriculture. The Committee acknowledged the first
request and the EPA staff responded to the second clarifying that they considered forestry
nursery use much more akin to agriculture and would be included in that definition while
plantation use would be excluded. The EPA noted the uncertainty around the use control and
noted that more specific additional statements could be provided to give regulatory certainty.
Sapere presentation
4.31 Sapere presented the economic analysis commissioned by the EPA. They outlined the scope
of the assessment, this being an estimation of the economic contributions of paraquat and the
effect of different restriction scenarios, primarily application rates and use patterns, from
minimal restriction to a total ban on paraquat, and the effect this would have, with GDP being
the measure of data.
4.32 Sapere explained that GDP was chosen as the data are readily available, easy to understand
and comparable to other studies. This approach used a New Zealand Institute of Economic
Research (NZIER) study which estimated the contribution of different crops to GDP as a base
point. From this point the contribution herbicides provided to crop yield was factored based on
an American study which was subsequently adapted to New Zealand conditions and then
factored by the proportionate role of paraquat. Sapere concluded that this resulted in a baseline
crop contribution from paraquat use of 39-75 million NZD per annum as value added income.
4.33 The assessment produced estimates of high and low scenarios which are based on the
percentage of herbicide value attributable to paraquat, and are considered a proxy for the
availability of substitutes or alternatives to paraquat. It was noted that for kūmara and lucerne
crops, the high and low values were the same reflecting the absence of alternative herbicides
to paraquat for these crops.
4.34 Sapere described the modelling of different scenarios based on application rate and frequency
restrictions which were used to ascribe benefits to the different use rates and which the EPA
could subsequently use to determine a balance between the risks and benefit for the
application rate restrictions. Sapere concluded that restriction to 300 g ai/ha application rate
would put 96% of the GDP estimate of paraquat at risk, while a 400 g ai/ha application rate
modelled about 33% of the estimated GDP to be at risk, while only around 2% of estimated
GDP was modelled to be at risk for a 600g ai/ha application rate.
4.35 Sapere outlined the assumptions and sensitivity analysis of the model as well as the
corrections and clarifications made for the model, based on the information provided by
submitters, and the effect these had on the modelling outcomes. It was noted that there was
little effect on the high value crops including kūmara, lucerne and clover. It was also clarified
that GDP acted as a measure of value added to the economy and this was chosen as the
modelling measure rather than the use of sales revenues.
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Committee questions
4.36 The Committee queried the value added for 600 g ai/ha uses noting that many use patterns
incorporated did not use that quantity. Sapere clarified that the values included all uses up to
and including 600 g ai/ha application rates and alternatively it can be considered that the use
patterns under the threshold are not affected and only those over that margin would lose their
value.
4.37 The Committee queried the application rate versus frequency values of some of the graphed
results. These were clarified by Sapere.
4.38 The Committee requested an explanation of the adaptation of the US study information to New
Zealand conditions. Sapere explained that an “island factor” was applied which acted as a
scalar to represent the different values of herbicides for different regions based on their
conditions. For Australia there was a factor of 1.45 while in New Zealand the factor was 0.46.
This scalar factor was then applied to the overall estimation equation. Sapere then undertook
sensitivity analysis on this factor to confirm its accuracy. Sapere also noted that the original US
study is a generic theoretical appraisal of the value of herbicides versus no herbicide use.
4.39 The Committee noted that there would be a variety of different inputs and different scenarios for
the use of paraquat and consequently a wide spectrum of scenarios for which the yield would
be impacted, leading to an expected greater confounding factor on the GDP and/or yield
modelled. The Committee noted that grower submissions may be able to assist here. Sapere
stated that their assessment applied the impacts of herbicides on different crop yields to
specific crops rather than across the board, however as there were no hard data on the share
of herbicides accounted for by paraquat for each crop type, this was applied across the board.
4.40 The Committee asked for clarification on the adjustment of the 2015 information to information
applicable to 2017. Sapere noted they originally used inflation rates and then upon consultation
with industry adjusted the GDP figures according to industry growth rates for different crop
sectors.
4.41 The Committee asked if Sapere was able to incorporate potential offsets from the use of
alternative herbicides or production methodologies, including organic production or production
in areas where paraquat is banned. Sapere noted the lack of hard data regarding different
alternatives to significantly justify altering the sensitivity analysis or any other results and noted
that any further analysis would require case studies or further primary research.
Submitter questions
4.42 Mr Salter questioned the accuracy of the GDP risks noting that a number of use scenarios are
captured as single application rates while the actual use is multiple applications at those rates
per year, such that the total application rate may exceed the proposed annual restriction.
Therefore he suggested that there would be GDP at risk which was not accounted for where a
single application was below the application rate restriction but the annual application rate
exceeded this. Sapere acknowledged that there may be some limitations to the analysis as the
original scope for which they requested grower information concerned a single application
annually.
4.43 Mr Parker (representing Federated Farmers and Market Access Solutionz) asked if the analysis
considered the effects on GDP for the livestock industries for clover and plantain growing
sectors. Sapere confirmed that their economic analysis incorporated the full production chain
including downstream effects of the crop as an input to GDP.
4.44 There were no further questions from submitters.
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WorkSafe presentation
4.45 WorkSafe presented a general overview of the WorkSafe regulations, priority of risk elimination
measures and the modification of controls using Safe Work Instruments (SWIs). WorkSafe also
provided commentary on the proposals made by the EPA, noting support for the decline of
approvals with additional hazards drawn from components other than paraquat.
4.46 WorkSafe then spoke to the proposed additional mitigation measures which may be applied by
way of an SWI, highlighting that the refined proposal had decreased the number of additional
mitigation measures. They indicated that the remaining proposed measures were closed cab
application and closed mixing and transfer system requirements. WorkSafe stated that they
would be seeking further information on the cost and practicability of these measures.
Committee questions
4.47 The Committee requested a further definition of closed cab technology and queried if any of the
Safe Work Instrument (SWI) measures were more defined. WorkSafe indicated that the
defining of any proposed SWI was still in progress and that they would be seeking and would
be open to information from industry which may assist in defining any requirements. The
Committee expanded on the question of SWI consideration noting the proposal for biosecurity
permissions to allow for use outside of the proposed restrictions on agricultural use. WorkSafe
stated that any controls set by WorkSafe either as prescribed requirements or SWIs would
apply regardless of the use type. They further stated that there may be concerns with increased
application rates or other uses where risks to workers may increase but noted that an SWI
would not be appropriate for a “one-off use” situation such as a permission.
Submitter questions
4.48 Antony Heywood from Horticulture New Zealand queried the presentation of death statistics
from hazardous substance use and whether there was any specific information regarding
paraquat. WorkSafe replied stating that they did not hold this information and clarified that with
deaths from chronic exposure it was difficult to assign specific exposures as being the trigger
for toxic effects.
Presentations by submitters
Federated Farmers (Ms Williams, and Mr Parker (Also spoke on behalf of Market Access Solutionz Limited))
4.49 Federated Farmers was the first submitter to present at the hearing. Ms Williams stated that
they had engaged Mike Parker, who has experience working for the Foundation for Arable
Research (FAR) to speak on behalf of their submission.
4.50 Mr Parker presented images depicting use of paraquat in the field, including an image of
paraquat application to clover seed crop in winter and commenting that the seed is very small
and the likelihood of any birds being present in areas where paraquat would be applied being
exceedingly remote.
4.51 The submitter then spoke to the advantages and use of paraquat. Mr Parker spoke to the uses
in clover seed production, plantain and lucerne, illustrating his comments with relevant images.
The submitter noted the effectiveness of paraquat in killing off weeds while only having a
knockback effect on clover, having a similar knockback effect with quick crop recovery in
plantain.
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4.52 The submitter noted that there were no alternatives for paraquat use in clover, plantain and
lucerne, noting that the closest alternative for plantains, dicamba, distorts the plant, while other
substances have phytotoxic effects on lucerne during the dormant stage of its lifecycle.
4.53 The submitter noted the importance of these crops to New Zealand as forage crops, noting that
plantain and lucerne were nitrogen fixing and that plantain was a low methane forage source.
Noting the benefits of these crops, Mr Parker suggested that there would be an increasing
effect on GDP moving forward.
4.54 Regarding the application rate, it was noted that 600 g ai/ha of paraquat was workable for
clover and plantain, and that it was the minimum rate required for efficacy with lucerne. The
submitter noted that lower rates were not sufficient to be effective and rates greater than 600 g
ai/ha would be preferred.
4.55 The submitter then spoke to his experience as a compliance certifier and the requirements and
controls imposed on the substance as well as the proposed additional controls and control
variations which may be set by both the EPA and WorkSafe. The submitter indicated that the
prescribed requirements including certified handler and PPE controls should be sufficient to
prevent exposures and additional controls are therefore not necessary and/or would not fully
eliminate the risks as intended. The submitter also noted that the formulations require
stenching agents and emetics and that the majority of recorded incidents related to intentional
misuse, absence of PPE or use outside of agricultural areas.
4.56 The submitter noted concerns around the definition of agriculture and that it would exclude
parks, golf courses, nurseries and that the intent should not prevent these uses.
4.57 Finally the submitter noted that paraquat plays a role in herbicide rotation to prevent
agrichemical resistance.
Committee questions
4.58 The Committee requested clarification that the use of paraquat on clover and plantain was for
seed crops only, which the submitter confirmed.
4.59 The Committee requested comment on the reliance on paraquat in New Zealand compared to
internationally, whether it is critical to the efficiency of the farming sector, what research had
been undertaken for alternative substances to paraquat and what published reference material
was available to support the lack of alternative substances for these use patterns. The
submitter highlighted the climate and soil conditions in New Zealand which contribute to weed
growth and the differences in the type of cropping being undertaken in other international areas
as key factors in the reliance on the herbicidal weed control.
4.60 Additionally, the submitter noted the proportionally greater importance of livestock agriculture to
New Zealand. The submitter was aware of research being undertaken but stated no
alternatives had been identified or were available. The EPA added to this point, noting that that
they were not aware of any published material and their assessment therefore focused on label
claims against similar weed types, furthermore, the submission responses indicated very
limited availability of alternatives for several uses.
4.61 The Committee asked about the uses in relation to the risks around birds, whether the use
and/or conditions would be likely to attract bird presence around the time of application or have
any effect on the likelihood of a bird to consume contaminated material. The submitter indicated
that the noise of application equipment would likely disturb the birds from being present in the
area during application, and that the substance dries quickly following application. They also
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indicated that the low application concentration on a smaller area scale (“probably 0.001 of a
gram per maybe half a metre”) would further reduce risks.
4.62 The Committee then asked what the timeframe was for paraquat to kill the plants. The
submitter indicated that it was dependant on the temperature with increased speed during
warmer months, with the mode of action affecting photosynthesis, and increasing efficacy when
photosynthesis systems are more active. In early spring it probably takes two-three days to
notice any browning.
EPA questions
4.63 The EPA noted that the submission for Federated Farmers indicated that the substance is used
as a desiccant on clover seed and requested information on when harvest would occur after
application. The submitter indicated that this would take place when the clover is mature and
would normally occur two-three days after application, but would depend on a number of
considerations including temperature, soil type and organic matter in the soil. The submitter
emphased to the Committee that growers took into account a number of considerations before
deciding to use any substance.
4.64 The EPA then asked about the number of applications which would be required or undertaken
from regeneration through to harvesting of clover seed, and if multiple applications are required
within an annual application rate limit of 600 g ai/ha, would they be able to use lower
application rates (e.g. 200 g ai/ha) multiple times or would a higher rate be needed per
application. The submitter stated that most growers would likely use one or two applications but
it would depend on the conditions of the area, weed growth and the weed spectrum/seed bank,
such that each grower would be different. They noted that there may be problems with using
lower application rates related to resistance management, so label rates would be used to
ensure an effective response.
Grower organisation presentations on behalf of Market Access Solutionz Limited's submission (Mr Salter (also spoke on behalf of Potatoes New Zealand), Mr De Bruin, and Mr Parker (also spoke on behalf of Federated Farmers)
4.65 Three presentations were made, one after each other, as part of a collective submission on
behalf of a number of different grower representative groups.
4.66 The first presentation concerned five horticultural grower groups, New Zealand Buttercup
Squash Council, Onions New Zealand, Processed Vegetables NZ, Summer Fruit New Zealand,
and Vegetables New Zealand. The submitter (Mr Salter) summarised their methods for
collecting information noting the significant response from some grower sectors such as
kūmara, and that they considered they could provide significant information to the decision
making process as a growers’ voice.
4.67 The submitter noted the contributions that the growing operations represented make to New
Zealand and in particular rural and regional specific activity, both in terms of economic benefit
but also regarding the employment and well-being of rural communities.
4.68 The submitter highlighted the benefits that paraquat provides to growers in these sectors,
including the substances rain fast, fast acting, contact and non-translocating properties, and
that the substance’s unique mode of action provides use in rotation to avoid herbicide
resistance.
4.69 The submitter then discussed the safe use of paraquat, with direct reference to poison centre
call data stating that the majority of calls are for improper use of paraquat or where an incident
has occurred with old equipment or containers of the substance. They also noted that outside
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of what the submitter has considered outlier years that there was a downward trend in all
incidents involving paraquat.
4.70 The submitter then addressed the risks to birds. The submitter noted a number of concerns
raised in the submission with assumptions made in the modelling. They highlighted that the
model assumes that weeds and weed seeds will be available as a food source, even when the
crop is unpalatable, whereas normal use patterns are undertaken early in the weed lifecycle
prior to seed generation to allow the substance to have a rapid effect.
4.71 The submitter also stated that the models do not appear to account for the substance not
translocating, such that the concentration of the substance in seeds would only occur from
contact with the herbicide spray. The submitter stated that these assumptions would mean that
residue unit dose used in the model would be greater than what would be available for
consumption for a bird. The submitter also suggested that using birds with similar diets to those
in the field in New Zealand would give a representative results in the modelling.
4.72 The submitter commented on the controls proposed by the EPA. The submitter supported the
more flexible approach to setting application rates, however noted that the proposed limit did
not allow for a number of use scenarios indicated by growers, in particular, worst-case
scenarios.
4.73 They also expressed concerns regarding the spray droplet size controls where, as a contact
herbicide, most growers used a finer spray to ensure coverage is achieved and the use of
paraquat is efficacious. The submitter noted that there was no problem envisaged with the
responsible handling provisions or buffer zone controls. Finally, the submitter noted that the
label change date is 24 months while the implementation period for the other controls was
proposed for 12 months, and that this may result in confusion for users. The submitter
proposed that the controls changes be aligned at 24 months.
4.74 The collective presentation then continued with Mr De Bruin presenting as a kūmara grower,
and as the chair of Vegetables New Zealand.
4.75 The submitter spoke to the importance of the kūmara industry to the Dargaville and Kaipara
areas noting that 80-90% of New Zealand’s kūmara comes from the area, with plants covering
2,000 hectares, with 200 people employed full time while there are a further 1,000 seasonal
workers – mostly local people, emphasising the importance to the local area.
4.76 The submitter noted the low tolerance of kūmara towards herbicides including paraquat, noting
that there was low tolerance for variance to the use pattern and spray timing which is
undertaken overnight so as to minimise the “burning” effect on the kūmara crop itself.
Furthermore, the submitter noted that the low tolerance of kūmara to herbicides meant that
there were no alternatives which would not kill the kūmara crop itself.
4.77 Speaking to the use pattern of paraquat on kūmara, the submitter noted there were little to no
birds present when they had sprayed, with the majority of bird life present on adjacent
paddocks with other uses, where greater seed would be present.
4.78 The submitter discussed the growth pattern of kūmara in relation to weed growth and chemical
control with herbicides. The submitter noted that the growing region for kūmara is prone to
conditions such that kūmara crops are highly vulnerable to weed growth resulting in low crop
yield and further weed bank development threatening subsequent years’ cropping.
4.79 The submitter also outlined why these conditions resulted in mechanical cultivation and weed
control not being feasible, further noting that hand weeding was only applicable in situations
where chemical weed control had already occurred. They noted that, with the exception of
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grass weed control, no further use of agrichemicals is required for kūmara following canopy
closure.
4.80 The submitter then summarised, noting that they only use paraquat when necessary and that
they are interested in using alternative methods of weed control where possible, and limit the
use of agrichemicals to where there is a critical number of weeds to control.
4.81 Mr Parker completed the collective presentation on behalf of vegetable growers other than the
kūmara growers already represented by Mr De Bruin.
4.82 Mr Parker outlined the use patterns of paraquat in combination with other weed control
methods for a number of crops. The submitter highlighted the usefulness of paraquat in hand
held knapsack spraying in that, as a contact herbicide, any off-target spray will only result in
minor damage to leaf tissue rather than translocating and killing the whole crop plant.
4.83 The submitter noted the importance of paraquat to resistance management, with a particular
emphasis on management of glyphosate resistance.
4.84 The submitter noted anecdotally that he had never seen birds in a paddock during spray
application, nor had he witnessed any bird death on his property.
4.85 The submitter noted the current risk mitigation methods including PPE and Growsafe
requirements and auditing, stating that these in combination with the use patterns would
mitigate the majority of risks associated with the use of paraquat in New Zealand such that
additional controls such as closed cab technology or closed mixing and loading technology for
hand use should not be mandatory. The submitter noted significant expense associated with
these risk mitigation measures.
4.86 Finally the submitter noted while that 600 g ai/ha would be acceptable as a maximum
application for their operations provided the timeframe was per crop or per season, with
mitigation from protective equipment, higher application rates should be acceptable.
Committee questions
4.87 The Committee noted the importance placed on paraquat by the presenters. The Committee
identified that similar crops may be produced by organic growers and that production still
appeared to be economically viable in areas where paraquat was not available. Therefore, the
Committee asked for comment on the implication that other methods of weed control may be
viable, noting that there was therefore room for innovation. Furthermore, the Committee asked
whether there would be risks to the vegetable industry and to food supply to the domestic
market if paraquat were removed. The submitters responded, noting that there are very few
organic operations and any production appears to be significantly limited in scale, with the
Committee noting that scale of production appears to be an issue which necessitates paraquat
use. One submitter noted that keeping the seed bank under control was an issue for organic
growers. The submitters also noted that there were differences in the soil and climate profiles
for those regions which made other herbicidal control regimes more successful, whereas the
climate and high organic content of soils in New Zealand resulted in a reliance on paraquat to
control weed growth.
4.88 The Committee then asked for comment on the timing and/or variability of paraquat use. The
submitters noted that the use of paraquat varies significantly and is dependent on a number of
different factors which the grower will account for. The Committee asked for further information
around the cropping season and the use of paraquat. The submitters noted that while kūmara
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has a single annual season, other crops would have multiple rotations in a year such that there
would be multiple crop cycles annually and therefore multiple inputs of paraquat.
4.89 The Committee queried whether the proposed application rate restriction would be an issue in
use. The Committee noted that this may create issues should an application rate control be set
per season rather than annually with diverse and potentially high use scenarios being
accounted for in different control scenarios. The submitter noted that it was after large rainfall
events where the use of the substance was critical for crops such as kūmara. The submitter
stated that if there was a number of these rainfall events such that the maximum application
rate was expended and weeds are left to grow then subsequent years will not allow for
sustainable cropping.
4.90 The Committee noted that there were a number of uses which were listed in the submitter’s
presentation which would not fit within a 600 g ai/ha limit and questioned what impact there
would be for those industries, noting that there were significantly higher uses for some crops
including perennial systems. The submitter noted that there was a lot of variability in the use
dependent on the conditions and that these higher uses were likely due to worst-case use
scenarios where a higher level of weed control is required.
4.91 The Committee then queried the submitter’s statements around droplet size noting that other
presentations had indicated that coarse droplets would be applicable. The submitter noted that
droplet size was applicable to drift and coverage but that there were a number of other factors
which also contributed to use and would need to be accounted for. The EPA noted in its
questions that they were not aware of use of finer spray droplets in general for herbicides and
that this may significantly affect the buffer zone sizes proposed to mitigate spray drift.
4.92 The EPA noted that for modelling the risks to birds the EPA followed the guidance outlined by
EFSA in addition to the refinements outlined by Syngenta in their submission.
EPA questions
4.93 The EPA asked about the use of paraquat on kūmara and queried how control was achieved
with methods other than increasing the application rate. The submitter stated that increased
rates are not used as they “burn” the kūmara plant, and any increase is minimal to cope with
hydrophobic issues without adversely affecting the plant.
Potatoes New Zealand presentation (Mr Salter (also spoke on behalf of Market Access Solutionz Limited’s submission))
4.94 The submitter (Mr Salter) began by outlining the scale of potato growing in New Zealand, noting
there are over 10,000 ha of planted potatoes, over half a million tonnes annual production and
around 2,500 people employed per year throughout the production chain. The submitter also
noted that the value of potatoes across the entire value chain has exceeded a billion dollars in
the most recent estimates. The submitter also noted that all fresh potatoes sold in New Zealand
are produced here.
4.95 The submitter then spoke to the use of paraquat on potatoes. The submitter noted that the
majority of sprayers use boom sprays, however, knapsack use is not uncommon. The submitter
stated that it is typically sprayed at the pre-emergent to emergent stage of crops, often with
medium nozzles. The submitter noted that use as a desiccant was very rare.
4.96 The submitter then noted the key advantages of paraquat including its role in resistance
management and herbicide rotation with paraquat having a unique mode of action, and its
mode of action as a contact only herbicide limiting phytosanitary risks to crops, especially those
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used for seed production which are more vulnerable to other alternative herbicides than mature
crops.
4.97 The submitter closed their presentation noting that the majority of the controls proposed by the
EPA were workable including buffer zones and the application rate limits, however there may
be issues with the droplet size restrictions. They also noted that they were in support of the
responsible handling information provisions.
Committee questions
4.98 The Committee queried the use of paraquat in resistance management and why diquat, with a
similar mode of action, is not used in this role. The applicant responded stating that for some
uses diquat is applicable, however for other uses such as use on kūmara, the damage from
diquat to the crop is significantly more extensive.
4.99 The Committee then queried the extent of work which has been undertaken to manage
potatoes without paraquat, and what work would be done should resistance to paraquat occur.
The submitters noted that a primary issue requiring the use of paraquat was the need to ensure
rotation was available to prevent resistance build up to other herbicides, and that an effective
rotation scheme was needed to prevent resistance in all herbicides involved in the rotation
including paraquat. The Committee noted that they would prefer if a comparable estimate in
value could be provided to account for the value of paraquat to herbicide resistance
management.
4.100 With no further questions the hearing was adjourned for the day to be continued on the
following day, 12 September 2019.
Horticulture New Zealand Presentation (Mr Heywood)
4.101 Horticulture New Zealand began their presentation by outlining the scope of their growers and
the industry value they represent, noting 5,000 commercial fruit and vegetable growers with an
industry value of around 5.5 billion dollars which includes exports to 120 countries. The
submitter (Mr Heywood) noted that 60,000 people were employed in the industry covering
130,000 hectares of land across the country.
4.102 The submitter noted their support for the statements issued in the other grower groups’
submissions.
4.103 The submitter emphasised that growers do comply with a hierarchy of controls when dealing
with hazardous substances and that Horticulture New Zealand would provide support to, and
work with, WorkSafe for any Safe Work Instrument.
4.104 Speaking to the application rate restrictions, the submitter supports the proposed application
rate control threshold of 600 g ai/ha, but would prefer that the rate is set seasonally rather than
annually to account for different rotations of vegetables being undertaken and the need to use
paraquat in response to weather events.
4.105 The submitter stated that they supported the use of hand-held applications as being essential
to allowing spot treatment and minimal chemical use for targeted application. The submitter
noted that a hierarchy of controls could be applied to mitigate the risks associated with the
substance.
4.106 The submitter stated that they do not agree with the proposal to revoke approvals which are not
currently in use. They argued that these approvals currently present no risk, and revocation
may present a future regulatory obstacle and reduce options for formulations which do not fit
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other existing formulation approvals. The submitter noted the high cost of the reassessment
and assessment process, both financially and in terms of the time required for development of
new chemistry, as well as the risks this presents to industry. The submitter noted the small size
of the New Zealand agrichemical market and the low incentive to develop new chemistry for
this market, such that it was important to maintain available tools such as paraquat which are
critical to grower operations.
Committee questions
4.107 The Committee asked the submitter to confirm their position regarding the maximum
application rate being seasonal rather than annual and noted that it was difficult to consider the
definition of need, and the difficulty in accounting for the apparent need of different industries
without clear evidence of this need. The submitter noted that the need was dependent on the
cropping scenario and would only reflect the needs of a specific situation and proposed that the
control should be a matter of confidence in good management practices.
4.108 The Committee noted that the submitter’s summary of risks around the approvals which were
not currently used was different to that of the EPA and queried the basis for this position. The
submitter responded stating that they did not want to close off the potential future benefits of
these substances and noting that it would come down to whether the hierarchy of controls
could manage any risks associated with the substances should they come into use.
4.109 The Committee asked the submitter to comment on the limitations that New Zealand growers
face in terms of access to chemistry compared to growers in overseas markets. The submitter
stated that, anecdotally, the toolbox in New Zealand was much more limited than that of
overseas markets and that this was believed to be constrained by the size of the market and
delays in the regulatory process.
4.110 The EPA then provided a point of clarification on the proposed revocation of approvals, noting
that the EPA considered there to be an inherent risk associated with the unused approvals as
the risk assessment for the existing products would indicate risks relevant to those substances
also. Further to this as there was no current use the EPA considered that these substances had
no benefits associated with them, and thus on a risk benefit balance it was considered that the
risks to maintaining the approvals outweighed the risks.
Syngenta presentation
4.111 The submitter noted that they had produced an additional presentation in response to queries
raised on the first day of the hearing and clarified with the Committee if it was acceptable to
present this as well as a presentation to their submission. The Committee consented to this.
4.112 The submitter outlined their participation in the reassessment including the submission of
studies and risk assessments during the call for information and submission stages of the
application.
4.113 The submitter spoke to the benefits associated with the use of paraquat and herbicides with
similar use patterns including its value in rotational herbicide use and the GDP contribution to
the New Zealand economy. The submitter noted the use of paraquat and glyphosate as “knock
back herbicides” and their use in conservation tillage to safeguard soil fertility, with
conservation tillage resulting in a 90% reduction in soil erosion.
4.114 It was noted that the mode of action of paraquat, which keeps the inactive root structure in
place, does not require cultivation resulting in retention of water and carbon storage in the soil.
The submitter noted that once sprayed, paraquat kills the weed and then becomes inactive in
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the soil, allowing for a rapid turnaround in planting and preparation of a paddock for cropping.
They noted that the use of this herbicide as opposed to hand weeding has a major impact in
reducing labour requirements.
4.115 The submitter then spoke to the role of paraquat in resistance management with particular
regards to glyphosate resistance. The submitter highlighted the use of double knock strategies,
where two consecutive applications are undertaken with different herbicidal modes of action,
such that any surviving weed is controlled preventing germination of weeds which may develop
increased resistance. The submitter noted that they had observed increased weed control and
better crop yields using these strategies. The submitter noted that there were increasing cases
of resistance to herbicide modes of action in weeds and that, with no new modes of action
being discovered, there was a necessity to ensure rotation through different modes of action.
4.116 The submitter outlined that they broadly supported the changes to the approvals and controls
proposed by the EPA. They noted that stenching and emetic agents are commonplace and
supported the entrenching of these in regulatory controls. Similarly they supported the provision
of responsible handling information, controls on wind speed at the time of application, and
restrictions on the transfer of products into unsuitable containers.
4.117 They also noted that there were data regarding spray droplet size which indicated that droplet
size is not critical to efficacy and that if this is required for regulatory control then it was
supported by Syngenta. Expanding on this point, the submitter stated that for a contact
herbicide a medium to coarse spray would provide better efficacy. The submitter noted that
they had run trials in Australia with contact herbicides targeting annual ryegrass as a difficult
weed to combat where efficacy was not sufficient. The submitter noted that for very coarse and
extra coarse spray there was a slight reduction in efficacy, but this was not considered to be
significant, and that coarse spray showed successful efficacy with both air induction and
conventional nozzles.
4.118 Syngenta stated that they supported the threshold of 600 g ai/ha as a maximum application
rate, but considered that this should be a single application rate limit as the substance binds
with the soil rapidly such that it is no longer bioavailable to birds. The submitter presented a
table of Soil Adsorption Coefficient (Kd) values around the adsorption of paraquat to different
soil types, noting that there was a strong trend for increased binding with increasing soil clay
content, however strong binding was observable for all soil types.
4.119 Addressing the possibility of bio-release of paraquat in a bird’s stomach, it was noted that the
conditions required for release of paraquat from soil required extreme acidity for a number of
hours which was not expected to be replicated in a bird’s stomach. Moreover, the applicant
noted that the toxicity information from feeding studies using contaminated material indicated a
significantly lower toxicity than acute studies, such that a release of paraquat is not being
observed, and dietary consumption would be expected to result in a greater exposure or risk to
the birds. Therefore, single exposure was considered to be the main point of concern.
4.120 The submitter continued, addressing the possibility of bioaccumulation or biomagnification,
noting that the substance has a low octanol/water partition coefficient, with a log POW of -4.5,
making it significantly more soluble in water than fat and unlikely to bioaccumulate (with the
regulatory threshold for bioaccumulation being considered to be log POW of ≥+3). They also
noted that in the metabolism studies for rodents and dogs there was a low absorption and
bioavailability observed, with the studies illustrating that the substance is rapidly distributed
through the body tissues and rapidly eliminated within 72 hours, with more than 90% eliminated
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in a short period. Finally the submitter noted that the deactivation of paraquat in soil particles
resulted in limited bioavailability.
4.121 The submitter then presented information on the development of their closed system
technology with regards to the consideration of Safe Work Instruments regarding this
technology. The submitter spoke to the benefits of this technology and addressed concerns
around the cost and whether mixing would still be required, and the integration of this
technology into existing tools.
Committee questions
4.122 The Committee noted that Syngenta supported the application rate limit for a single application
but did not propose this as a maximum over a time period. The submitter stated that there was
strong evidence for limited chronic effects associated with paraquat use, noting that a number
of long-term studies on the effects of paraquat over ten or more years had been undertaken in
different locations around the world, which illustrated a limited chronic effect. The Submitter
noted that the substance binds to the soil, with strong data to illustrate that it is not bioavailable
and that, if released from the soil, it rapidly breaks down with a short half-life.
4.123 Furthermore, studies on the equilibrium of paraquat in the soil and bore water illustrate that
there is a significantly limited effect. Therefore, providing the substance was used judiciously
according to the standard use pattern, the substance would not lead to a cumulative effect. The
submitter also noted that the bird data on repeat dose of consumption provide an endpoint
which supports multiple uses of paraquat at a 600 g ai/ha single application rate.
4.124 The Committee asked for further information around resistance management and what the
response would be if resistance develops to paraquat. The submitter noted that rotation would
become more important in that scenario, with rotation used to protect different chemistries and
modes of action by slowing the rates of resistance. The submitter noted that new modes of
action (to be used in resistance management) were not currently foreseen. The submitter also
noted that there were issues with other technology developments to aid alternatives to
herbicide use and that these would have other impacts which would need to be balanced, such
as the effect on soil moisture and fertility.
4.125 The Committee noted that it was the inherently high acute risks from the substance that were of
main concern for the use of paraquat. The submitter agreed and noted that they supported
stringent measures to control the use of the substance including developing mitigation tools
that could be applied where PPE and other standard management options were not sufficient.
EPA and WorkSafe questions
4.126 The EPA asked if the submitter could clarify the relationship between crop protection use of the
herbicide and the use of paraquat as part of a herbicide resistance strategy. The submitter
noted that the two aspects were integrated and that there would be an agronomic need to apply
a substance for crop protection while the selection of what substance and how to apply the
substance would be a resistance management consideration.
4.127 The EPA asked if the long-term studies mentioned incorporated the effects on birds,
invertebrates, soil organisms and the wider spectrum of ecotoxicological events. The submitter
acknowledged that the studies focused on the accumulation in the soil, its availability and the
fate of paraquat in the soil environment. The submitter acknowledged that they were not aware
of whether other bio-indicators were used in this assessment.
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4.128 WorkSafe then asked if the submitter could outline the use of closed systems in Australia and if
there was any regulatory requirement for these systems. The submitter noted that this was not
yet a regulatory requirement, however there was an increasing trend towards the availability of
these technologies. The submitter also noted that there was coordination in the industry to
ensure that there were singular systems for these technologies rather than having different
systems designed for different products.
4.129 The EPA clarified that the application limitations around multiple applications were somewhat
derived from the inability to eliminate uncertainty from the modelling around multiple
applications. The resultant quantitative modelling showed some residual accumulated risks
which could not be accounted for quantitatively. While this may not represent the real world
scenario where multiple applications may be able to take place within a threshold, the
uncertainty around these risks could not be resolved. Therefore in order to maintain a level of
certainty around the risks, the EPA has proposed the annual limitation.
4.130 The EPA also noted that the responsible handling provisions were in part to account for the
long history of paraquat use, and to account for the associated complacency around the risks
associated with the substance, as well as highlighting the new requirements associated with
the substance.
4.131 This concluded the submitter presentations.
Applicant/EPA right of reply
4.132 The EPA clarified the intention of the proposed restriction to agricultural use, noting that they
intended that it would encompass cropping style situations, including production horticulture
with rows of ornamental plants grown for commercial purposes, and that there was an express
intent not to include use in places of public amenity or any home use scenarios which would be
considered to be a workplace because the substance was applied by a professional contractor.
4.133 The EPA then clarified the biosecurity permission provisions. The EPA highlighted the
submission from Biosecurity New Zealand indicating that the restrictions proposed for
agricultural use would not allow them to operate effectively. Biosecurity operations may provide
significant benefits, which may allow for a higher degree of risks to be acceptable but which
could also result in the application of additional or different controls which are not applied to
agricultural uses. The EPA noted that the permissions scheme would allow for the case by
case assessment of the benefits, risk tolerance and the setting of additional restrictions where
appropriate.
4.134 The EPA then addressed the phase in of controls, information provisions and labelling
requirements. The EPA noted that they considered a benefit in applying a 12-month phase in
period for the majority of controls and that they envisioned that users would be made aware of
new restrictions by the responsible handing provisions and through the use of additional
labelling items such as lid stickers to alert users to any changes.
4.135 Speaking to the risks to birds, the EPA considered there to be unmitigated chronic risks. The
EPA acknowledged the submitters’ anecdotal evidence regarding bird presence in application
areas, noting that these were anecdotal observations. They also noted that DoC submitted that
birds and other wildlife would be present in cropping and horticulture areas, however they noted
that these were again anecdotal observations. The EPA noted a shortage of literature relating
to birds and their living habits in agricultural environments, such that determining the type and
number of birds present would require more detailed observation.
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4.136 The EPA continued, noting that Syngenta submitted that multiple applications would behave as
a series of single applications without accumulated effect, and stating that the EPA disagreed
with this assessment. It was noted that the study where this was undertaken involved feeding of
a paraquat treated food supply, and that where paraquat was applied with multiple applications
the food supply for birds (insects and seeds) would receive continual dosing on each additional
application and therefore the risk assessment was refined to account for the proportion of bird
diets which would be contaminated at the time of year paraquat is typically applied.
4.137 The EPA noted that the risks associated with allowing multiple applications at up to 600 g ai/ha
per application were considered to outweigh the benefits that would be associated with allowing
multiple applications at this application rate under this risk assessment.
Committee questions
4.138 The Committee requested that the EPA ensure that the definition of horticulture is clarified to
ensure that the intended exclusion is accurately captured, whether this involves excluding
amenity horticulture or specifying that the definition is intended to include floriculture.
4.139 The Committee requested clarification on whether the application rate is proposed as annual or
seasonal. The EPA highlighted that some crop rotations may involve multiple rotations within a
single year such that a seasonal definition would allow for significantly higher use rates such
that the intended risk mitigation is not achieved. The EPA stated that it would not be simple or
effective to set different controls for different use patterns or more complicated controls which
allowed for flexibility with restriction over a greater time period, and furthermore to do so would
require a complicated and extensive risk assessment. Therefore, the EPA supports an annual
application rate restriction.
4.140 The Committee requested clarification around the chronic risk studies for birds. The EPA
responded, outlining that the studies are performed over a long period of time in which the
parent birds are fed contaminated food, equivalent to a repeat chronic exposure and the study
accounts for effects other than just the survival of the birds.
4.141 At this point there were no further questions or presentations.
4.142 The hearing was adjourned on 12 September 2018. After clarifying a number of outstanding
points with the EPA (discussed in the Post hearing considerations section below), the
Committee closed the hearing on 14 October 2019.
Post hearing considerations
4.143 The EPA contacted the Committee requesting direction or confirmation on a number of points.
4.144 Regarding the definition of agriculture, specifically ensuring the allowance for horticulture
outside of public amenity areas, the Committee directed the EPA to have the definition of
agriculture worded as follows:
“agricultural purposes includes use for agricultural and production horticulture purposes, but
does not include use for forestry plantation or biosecurity purposes. Production horticulture
includes commercial cropping systems and commercial ornamental horticulture production, but
excludes amenity horticulture in publicly accessible areas or horticulture areas which would
otherwise be considered domestic properties.”
4.145 The committee also received questions from a submitter regarding assumptions in the
modelling which were identified but not considered by the applicant to have been addressed by
the EPA in the hearing. The Committee directed the EPA to prepare a response to these
questions and reviewed this response but noted that they had sufficient information to proceed
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with a decision. This response was addressed in a minute from the Committee “Addendum to
WGT0001: direction & minute”.
4.146 The Committee considered whether further definition and direction was required from the
Committee regarding the scope and direction for permissions for biosecurity uses and whether
the Committee should engage with Biosecurity NZ on these matters. The Committee
considered that the proposed wording of the control and its reference to the Biosecurity Act
provided sufficient direction and that further consultation or assessment from the Committee
was not required on this matter.
4.147 The Committee considered the need to issue a direction for disposal for substances which are
proposed to have their approvals declined by the reassessment decision. The Committee
considered that a clear direction should be issued on this matter but that the details and
enactment of this process could be undertaken separately to the decision process.
5 Consideration
Information available for consideration
5.1 The information available to the Committee for consideration of this application consisted of:
the application form
the EPA update report
the submissions
information received from WorkSafe
previous EPA risk assessments
updated EPA risk assessment specific to this reassessment
EPA cultural assessment
hearing presentations made by the EPA and the submitters
addendum to hearing WGT0001: direction & minute.
5.2 After considering all relevant information, the Committee decided that it had sufficient
information to make a decision on this application. Further comments on this information can be
found below.
Hazardous properties
5.3 The hazardous properties of paraquat have been revised since the original application as new
information was available to inform a review of the hazards. The updated classification of
paraquat is summarised in Table 1 below. The classifications of paraquat-containing
substances are consequently also updated and the updated classification for the retained
approvals are shown in Tables 2 and 3 below.
Table 1 Hazard classifications of paraquat (HSR003041)
Hazard Classification
Acute toxicity (oral) 6.1C
Acute toxicity (dermal) 6.1E
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Acute toxicity (inhalation) 6.1A
Skin irritancy/corrosivity 6.3B
Eye irritancy/corrosivity 6.4A
Target organ or systemic toxicity (oral) 6.9A
Aquatic ecotoxicity 9.1A
Terrestrial vertebrate ecotoxicity 9.3B
Terrestrial invertebrate ecotoxicity 9.4B
Table 2 Hazard classifications of Soluble concentrate containing 115 g/litre diquat as the
dibromide salt and 135 g/litre paraquat as the dichloride salt (HSR000447)
Hazard Classification
Acute toxicity (oral) 6.1B
Acute toxicity (dermal) 6.1B
Acute toxicity (inhalation) 6.1A
Skin irritancy/corrosivity 6.3A
Eye irritancy/corrosivity 6.4A
Contact sensitisation 6.5B
Target organ or systemic toxicity (oral) 6.9A
Aquatic ecotoxicity 9.1A
Terrestrial vertebrate ecotoxicity 9.3A
Terrestrial invertebrate ecotoxicity 9.4B
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Table 3 Hazard classifications of Soluble concentrate containing 200 - 250 g/litre paraquat as
the dichloride salt (HSR000828)
Hazard Classification
Acute toxicity (oral) 6.1C
Acute toxicity (dermal) 6.1E
Acute toxicity (inhalation) 6.1A
Skin irritancy/corrosivity 6.3A
Eye irritancy/corrosivity 6.4A
Target organ or systemic toxicity (oral) 6.9A
Aquatic ecotoxicity 9.1A
Terrestrial vertebrate ecotoxicity 9.3B
Terrestrial invertebrate ecotoxicity 9.4B
Proposed modification of controls
5.4 The suite of controls proposed by the EPA, and considered by the Committee are detailed in
full in Appendix A of the EPA update report. The control suite includes:
prescribed controls, that is those triggered by the hazard classifications of paraquat and
the other excipient components in paraquat-containing substances
variations to the prescribed controls in accordance with section 77 of the Act
additional controls, proposed in accordance with section 77A of the Act.
Assessment of risks
5.5 The Committee took into account the EPA risk assessment for paraquat and
paraquat-containing substances, as detailed in the EPA update report. The key points are
summarised below.
Risks during manufacture, packaging, importation, transportation, storage and disposal
5.6 The Committee noted that the risks during manufacture, packaging, importation, transportation,
storage and disposal will remain at a negligible level, given that exposure is unlikely to occur
and that the proposed controls and other legislative requirements will sufficiently mitigate the
risks associated with these stages of the substance lifecycle. These include the existing EPA
Notices around packaging, identification, emergency management and disposal of hazardous
substances, the Land Transport Rule 45001, Civil Aviation Act 1990, Maritime Transport Act
1994 and New Zealand’s health and safety at work requirements.
Risks during use
5.7 The Committee noted that there is the potential for exposure to humans and the environment to
occur during the use phase of the substance and considered the human health and
environmental risk assessments provided by the EPA.
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Human health effects
5.8 The Committee noted that the predicted exposures during mixing, loading and application by
operators, and for bystanders for the agricultural use patterns at a maximum application rate of
600 g ai/ha, including aerial application with coarse droplets, resulted in risk quotients below
the acceptable operator exposure level (AOEL). The Committee noted that dermal exposure
during re-entry would not likely occur with the use patterns associated with paraquat and
therefore restricted entry intervals were not seen as necessary or modelled.
5.9 The Committee noted that the estimated bystander exposure from spray drift for aerial forestry
use is above the AOEL and would require a buffer zone. However the Committee also noted
that this use pattern would be excluded by the EPA’s proposed use restriction.
5.10 The Committee noted the conclusions of the science memo, that application rates up to and
including 600 g ai/ha using boom or aerial application methods are acceptable, providing that
full PPE including respiratory protection is used, whereas application rates above this rate
result in exposures exceeding the AOEL, even with full PPE. The Committee noted that
backpack application rates up to 390 g ai/ ha with full PPE and respiratory protection result in
exposures below the AOEL.
5.11 The Committee noted that the approvals HSR100443 and HSR100572, had formulations
containing components which would trigger additional CMR classifications which were not
triggered by paraquat. The Committee noted that these substances would present a higher risk
than the other substances subject to this reassessment. The Committee also noted that the
WorkSafe hierarchy of risks elimination suggests that these substances should not be used
where there is an alternative with a similar beneficial effect and that WorkSafe therefore
supported the revocation of these approvals.
Responsible handler provisions
5.12 The Committee considered the provision of responsible handling information requirements as
proposed by the EPA, noting that Syngenta supported this proposal in their submission. The
Committee noted the EPA’s justification around the long timeframe that paraquat has been in
use and that there may be some associated complacency and reluctance to uptake the new
requirements or update practices to safely use the substance. The Committee considered that
the responsible handling information provisions would assist in mitigating the human health
risks associated with paraquat and updating to safer use practices which are supported by the
other proposed controls.
Environmental effects
5.13 The Committee noted the conclusions of the science memo and risk assessment prepared by
the EPA.
Risks to the aquatic environment
5.14 The Committee noted that the predicted concentration of paraquat in the aquatic environment
without additional or varied controls is above the LOC. The Committee noted that additional
controls limiting the maximum application rate and applying use restrictions on droplet size
would reduce spray drift and reduce the risks to below the LOC.
Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators
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5.15 The Committee noted the EPA’s risk assessment conclusions that the risks to groundwater,
sediment-dwelling soil organisms and non-target arthropods are all below the LOC.
Risks to non-target plants
5.16 The Committee noted the risk assessment outcomes regarding non-target plants, where the
risks from spray drift are above the LOC. The Committee considered that the EPA’s proposal to
apply downwind non-target buffer zones to the product label would mitigate the risks to non-
target, threatened and non-threatened plants.
Risks to pollinators
5.17 The Committee noted the risk assessment conclusion regarding risks to pollinators, where the
risks to bees is above the LOC for all use patterns above an application rate of 100 g ai/ha,
however it also notes the qualitative conclusions that many of the use patterns are scenarios
where exposure to bees is expected to be minimal. Furthermore, the Committee notes that
clause 58 of the HPC Notice will apply such that any user must ensure that bees and non-
target pollinators are not in the application plot nor likely to visit the application plot.
Considering these factors, the Committee agreed with the EPA risk assessment conclusion that
the risks to pollinators would be mitigated to below the LOC with controls applied.
Risks to sediment-dwelling organisms, non-target arthropods soil organisms, and pollinators
5.18 The Committee noted that there were unknown risks from the persistence of the substance in
the soil environment, including the effect on long-term soil fertility, and the effect on different
soil types. The Committee accepted that the soil persistence information needed to be generic
to cover risks with all soil types in New Zealand and therefore a conservative approach was
taken for this aspect of the assessment.
Risks to birdlife
5.19 The Committee noted the EPA risk assessment conclusion that the risks to birds are above the
LOC and are non-negligible. The Committee considered the risks to birds to be a key factor to
the overall ecotoxicology risk assessment, and the risk benefit assessment as a whole.
5.20 The Committee considered the issue of ecotoxicological risks to birds. The Committee noted
that there was a potential disconnect between the theoretical risk and the actual risks for birds.
The Committee acknowledged the perspectives provided by submitters which suggested that
the risks to birds seemed unlikely to exist, however they noted that the modelling undertaken by
the EPA still indicated a risk.
5.21 The Committee noted the lack of advocacy for birds in the submissions both written and heard
at the hearing compared to applications for similar substances. The Committee noted this may
result from a lack of resource to reliably quantify bird behaviour and the actual risks to birds
from a substance with known toxicity to birds and that this made the Committee’s position on
determining this risk difficult.
5.22 The Committee considered that the risk to birds was an outstanding risk which could not be
mitigated by the prescribed controls or the additional control set.
5.23 The Committee considered that, based on the balance of risks to birds to benefits, the
maximum annual and single application rate of 600 g ai/ha would be appropriate.
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Assessment of risks to society, the community, and the market economy
5.24 The Committee did not identify any risks to society, the community and the economy
associated with the approval of paraquat herbicides, other than those considered previously.
The Committee therefore did not consider this further.
Assessment of benefits
5.25 The Committee noted the benefits to communities and the economy raised in the application,
the EPA update report, and in the associated economic analysis, as well as the information
provided in the submitters’ subsequent questions, submissions and in submitter presentations.
5.26 The Committee noted that there were gaps in the assessments regarding aspects of benefits
on the community and the market economy. In particular, the Committee noted that there was
limited to no information on the regional impact of paraquat herbicides and there was little
information on organic agriculture and horticulture practices for the use patterns associated
with paraquat. The Committee considered that these were significant gaps in considering the
economic value and reliance on paraquat for different sectors.
5.27 The Committee noted the EPA summary that the majority of benefits were present in the
agriculture and horticulture sectors, and that the information from submitters indicated little
benefit from the use of paraquat in forestry plantations.
5.28 While the Committee acknowledged that there were absences in the information available, they
considered that there was sufficient information available regarding the use patterns for
paraquat to assert that the majority of uses would be covered by the proposed application rate
restriction of 600 g ai/ha as a maximum single and a maximum annual application rate.
5.29 The Committee noted the benefits outlined in the EPA update report and in the information
provided in the form of submissions. Furthermore, the presentations at the hearing from grower
and agricultural representatives demonstrated benefits of the use of paraquat herbicides. The
Committee noted that there were key benefits to specific agricultural industries from paraquat
and that the EPA and submitter presentations noted that there were few if any alternatives to
paraquat are available for these uses.
5.30 The Committee noted that there were benefits associated with biosecurity uses, that these
benefits were non-negligible, and that these may require application rates outside of the
restrictions applied to agricultural use. The Committee considered that these benefits could be
assessed against the associated risks through a permission under section 95A of the Act. The
Committee considers that biosecurity use of paraquat should only allow for those uses defined
under the Biosecurity Act 1993, by the relevant competent agencies as described under that
Act, and other interpretations of this use pattern should not be allowed. Therefore the
Committee considered that the permission control should directly reference the Biosecurity Act.
5.31 The Committee considered the proposed benefits and assessed them as non-negligible.
5.32 The Committee considered the substances where there were no registered products
(HSR007847 and HSR007854). The Committee noted that the originator of these approvals
supported the revocation of these approvals. The Committee therefore concluded that these
approvals have little to no benefit and that this should be accounted for in the assessment to re-
approve or decline these substances. The Committee considers that these approvals should
therefore be declined, with this to come into effect 12 months following the date of the decision.
5.33 The Committee considered the approvals which had CMR classifications which were not
triggered for the other approvals (HSR100443 and HSR100572). The Committee considered
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that these approvals did not provide any additional benefits when compared to the substances
proposed for re-approval. The Committee considers that these approvals should therefore be
declined, with this to come into effect 12 months following the date of the decision.
5.34 The Committee noted that the intellectual property owner for paraquat, Syngenta, supported
declining approvals in their submission.
Cultural assessment
5.35 The Committee noted that the EPA assessed the potential effects on the economic, social, and
cultural well-being of Māori, and the relationship of Māori to the environment, in accordance
with sections 5(b), 6(d) and 8 of the Act.
5.36 The Committee considered that with the controls proposed in place, the impact of use of
paraquat herbicides on the relationship of Māori to the environment would be negligible. The
Committee considered that the application is likely to be consistent with the principles of the
Treaty of Waitangi.
New Zealand’s international obligations
5.37 The Committee noted there were no international obligations regarding paraquat
Amendments to proposed controls by the Committee
5.38 In accordance with section 29 of the Act, the Committee took into account the proposed suite of
controls and noted that these aligned with best international practice for the mitigation of risks
posed to human health and the environment by hazardous substances.
5.39 The Committee did not consider any amendments to the controls proposed by any submitters.
5.40 The Committee considered that the setting of a maximum annual application rate and a
maximum single application rate of 600 g ai/ ha as proposed by the EPA would encompass the
majority of use patterns while, in combination with the other proposed controls, would mitigate
the majority of human health and ecotoxic risks, and therefore provide the best balance
between the non-negligible benefits and risks associated with the use of paraquat containing
substances.
5.41 The Committee determined that the controls detailed in Appendix A will apply as soon as this
decision is published or at the latest at the end of the transitional period specified in Tables A-1,
A-2, A-3 and A-4 in Appendix A.
5.42 The Committee noted that the controls for human health risks in a workplace, including any
associated Safe Work Instruments, are administered by WorkSafe rather than the EPA and
therefore were outside the scope of consideration. While these workplace controls ultimately
were not determinative of the Committee’s decision, the Committee expressly recommended
that requirements for closed systems should be adopted for handheld and closed cab wide
dispersive use patterns.
Direction to dispose of substances with declined approvals
5.43 The Committee have considered that substances with approvals which will be declined will
need to be disposed of once the decision comes into effect. The Committee consider that the
direction for disposal will be set out in a Notice in the New Zealand Gazette as required by s66
of the HSNO Act which will be issued subsequent to this decision. This direction to dispose will
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come into effect 12 months after the date of the decision when the effect of the decision to
decline these approvals takes effect.
Guidance on packaging requirements
5.44 The Committee noted that under the previous hazardous substances packaging regulations
(revoked), the packaging control for paraquat was varied to apply packing group III rather than
the packing group I. In the previous controls and decision it was noted that the oral and dermal
routes of toxicity, which have a lower classification, were more likely to be realised in this stage
of the substance’s lifecycle than the inhalation toxicity which triggers the higher 6.1A acute
toxicity classification, and therefore the packing group was set as packing group III to reflect the
level of risk associated with the applicable routes of toxicity. The Committee notes that under
the new Packaging Notice, which will apply as a prescribed control to any new approval, the
packaging requirements for the substance directly correspond to the Recommendation on the
Transport of Dangerous Goods Model Regulations which allow for paraquat to be packaged in
packing group I, II or III. The committee considers that packing group III remains appropriate for
paraquat and that this shall be illustrated in the following guidance note to be attached to the
packaging notices control:
“Guidance note: Paraquat may fall under Packing group I, II or III under the Recommendation
on the Transport of Dangerous Goods Model Regulations. The EPA considers that Packing
Group III is appropriate for paraquat containing substances.”
6 Conclusion and decision
6.1 Pursuant to section 29 of the Act and section 32 of the Hazardous Substances and New
Organisms (Methodology) Order 1998 (“the Methodology”), the Committee considered this
application to reassess paraquat and paraquat-containing substances. In doing so, the
Committee applied all the relevant sections of the Act, including those set out in Part 2, and
clauses of the Methodology, as detailed in Appendix B.
6.2 The Committee considered all the effects associated with the substances Paraquat
(HSR003041), Soluble concentrate containing 115 g/litre diquat as the dibromide salt and 135
g/litre paraquat as the dichloride salt (HSR000447) and Soluble concentrate containing 200 -
250 g/litre paraquat as the dichloride salt (HSR000828). The Committee considered that the
variations to the prescribed controls and the additional controls proposed by the EPA should be
applied to mitigate the risks associated with the substances. It is considered that there may be
non-negligible risks to birds associated with paraquat containing substances even with the
proposed control set and that these risks could not be managed with further additional controls.
The Committee considered that there are significant non-negligible benefits associated with
paraquat containing substances and that these benefits were sufficient to outweigh the risks
associated with the paraquat containing substances approved under Paraquat (HSR003041),
Soluble concentrate containing 115 g/litre diquat as the dibromide salt and 135 g/litre paraquat
as the dichloride salt (HSR000447) and Soluble concentrate containing 200 - 250 g/litre
paraquat as the dichloride salt (HSR000828). It was, therefore, considered that the positive
effects of paraquat containing substances outweigh the adverse effects and that these
substances should be approved under this reassessment.
6.3 The Committee considered that the paraquat containing substances Uniquat 250 (HSR100443)
and Parable 250 (HSR100572) triggered additional classifications which were triggered by
components other than paraquat, such that there are additional non-negligible risks to human
health associated with these substances. The Committee considered that there was no
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evidence to suggest that the inclusion of the components triggering these classifications would
provide any additional benefits to the use of a paraquat containing substance. They considered
that the non-negligible risks associated with these formulated substances would outweigh the
benefits and that the approvals for these approvals therefore be declined. The effect of this
decision comes into effect 12 months following the date of decision.
6.4 The Committee considered the proposal that those paraquat containing substances
(Gramoxone Inteon (HSR007847) and Preeglone Inteon (HSR007854)) which do not have any
products registered under the ACVM Act provided no benefits as they were not in use, and
agreed that there were negligible benefits associated with these substances. These substances
have non-negligible risks. The Committee therefore considered that the positive effects of these
substances were outweighed by the adverse effects and that the approvals should therefore be
declined. The effect of this decision comes into effect 12 months following the date of decision.
6.5 In making its decision, the Committee took into account best international practices and
standards for the safe management of hazardous substances.
6.6 Consequently, the Committee determined that the approvals Paraquat (HSR003041), Soluble
concentrate containing 115 g/litre diquat as the dibromide salt and 135 g/litre paraquat as the
dichloride salt (HSR000447) and Soluble concentrate containing 200 - 250 g/litre paraquat as
the dichloride salt (HSR000828) are approved with additional controls and that the approvals
Decision on the reassessment of paraquat and paraquat-containing substances (APP203301)
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Appendix B: Decision path
Context
This decision path describes the decision-making process for applications for a reassessment of
hazardous substances approvals. These applications are made under section 63 of the HSNO Act
and determined pursuant to s29.
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Decision path for applications to import or manufacture a hazardous substance, application made under section 63 of the Act and determined under section 29.
For proper interpretation of the decision path it is important to work through the flowchart in
conjunction with the explanatory notes.
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Explanatory Notes
Item 1: Review the content of the application and all relevant information
Review the application, the E&R Report, and information received from experts and that
provided in submissions (where relevant) in terms of section 28(2) of the Act and clauses 8,
15, 16 and 20 of the Methodology.
Item 2: Is this information sufficient to proceed?
Review the information and determine whether or not there is sufficient information available to
make a decision.
The Methodology (clause 8) states that the information used by the HSNO decision maker in
evaluating applications shall be that which is appropriate and relevant to the application. While
the HSNO decision maker will consider all relevant information, its principal interest is in
information which is significant to the proper consideration of the application; ie information
which is “necessary and sufficient” for decision-making.
Item 3: (if “no” from item 2) Seek additional information
If there is not sufficient information then additional information may need to be sought from the
applicant, EPA staff or other parties/experts under section 58 of the Act (clause 23 of the
Methodology).
Item 4 Sufficient?
When additional information has been sought, has this been provided, and is there now
sufficient information available to make a decision?
If the HSNO decision maker is not satisfied that it has sufficient information for consideration,
then the application must be declined under section 29(1)(c).
Item 5: (If “yes” from item 2 or from item 4) Identify the composition of the substance, classify the hazardous properties, and determine default controls
Identify the composition of the substance, and establish the hazard classifications for the
identified substance.
Determine the default controls for the specified hazardous properties using the regulations
“toolbox‟.
Item 6: Identify all risks, costs and benefits that are potentially non-negligible3
Costs and benefits are defined in the Methodology as the value of particular effects (clause 2).
However, in most cases these “values‟ are not certain and have a likelihood attached to them.
Thus costs and risks are generally linked and may be addressed together. If not, they will be
addressed separately. Examples of costs that might not be obviously linked to risks are direct
financial costs that cannot be considered as “sunk‟ costs (see footnote 1). Where such costs
arise and they have a market economic effect they will be assessed in the same way as risks,
but their likelihood of occurrence will be more certain (see also item 11).
Step 1: Identify all possible risks and costs (adverse effects) and benefits (positive
effects) associated with the approval of the substance(s), and based on the
range of areas of impact described in clause 9 of the Methodology and
sections 5 and 6 of the Act3. Consider the effects of the substance through its
3 Effects on the natural environment, effects on human health and safety, effects on Maori culture and traditions,
effects on society and community, effects on the market economy.
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lifecycle (clause 11) and include the likely effects of the substance being
unavailable (sections 29(1)(a)(iii) and 29(1)(b)(iii)).
Relevant costs and benefits are those that relate to New Zealand and those
that would arise as a consequence of approving the application (clause 14).
Consider short term and long term effects.
Identify situations where risks and costs occur in one area of impact or affect
one sector and benefits accrue to another area or sector; that is, situations
where risks and costs do not have corresponding benefits.
Step 2: Document those risks, costs and benefits that can be readily concluded to be
negligible4, and eliminate them from further consideration.
Note that where there are costs that are not associated with risks some of
them may be eliminated at this scoping stage on the basis that the financial
cost represented is very small and there is no overall effect on the market
economy.
Item 7: Assess each risk assuming controls in place. Add, substitute or delete controls in accordance with clause 35 and sections 77, 77A and 77B of the Act.
The assessment of potentially non-negligible risks and costs should be carried out in
accordance with clauses 12, 13, 15, 22, 24, 25, and 29 to 32 of the Methodology. The
assessment is carried out with the default controls in place.
Assess each potentially non-negligible risk and cost estimating the magnitude of the effect if it
should occur and the likelihood of it occurring. Where there are non-negligible financial costs
that are not associated with risks then the probability of occurrence (likelihood) may be close
to 1. Relevant information provided in submissions should be taken into account.
The distribution of risks and costs should be considered, including geographical distribution
and distribution over groups in the community, as well as distribution over time. This
information should be retained with the assessed level of risk/cost.
This assessment includes consideration of how cautious the HSNO decision maker will be in
the face of uncertainty (section 7). Where there is uncertainty, it may be necessary to estimate
scenarios for lower and upper bounds for the adverse effect as a means of identifying the
range of uncertainty (clause 32). It is also important to bear in mind the materiality of the
uncertainty and how significant the uncertainty is for the decision (clause 29(a)).
Consider the HSNO decision maker’s approach to risk (clause 33 of the Methodology) or how
risk averse the HSNO decision maker should be in giving weight to the residual risk, where
residual risk is the risk remaining after the imposition of controls.
See EPA report “Approach to Risk‟ for further guidance5
Where it is clear that residual risks are non-negligible and where appropriate controls are
available, add substitute or delete controls in accordance with sections 77 and 77A of the Act
to reduce the residual risk to a tolerable level. If the substance has toxic or ecotoxic properties,
consider setting exposure limits under section 77B. While clause 35 is relevant here, in terms
of considering the costs and benefits of changing the controls, it has more prominence in items
10 and 13
4 Negligible effects are defined in the Annotated Methodology as “Risks which are of such little significance in
terms of their likelihood and effect that they do not require active management and/or after the application of
risk management can be justified by very small levels of benefits.